欧盟 PSUSA 对狂犬病疫苗活性成分的定期安全性更新报告单次评估结果：维持现状

PSUSA/00009277/202603

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欧盟 PSUSA 程序对狂犬病疫苗所含活性成分的相关定期安全性更新报告（PSUR）完成单次评估，程序编号 PSUSA/00009277/202603，监管结论为维持现状（Maintenance）。PSUSA 是对欧盟已授权药品活性成分相关 PSUR 的单次评估，PSUR 由上市许可持有人在授权后规定时间点定期提交。

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About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure: rabies vaccine
Procedure number: PSUSA/00009277/202603
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu